Understanding implementation of a complex intervention in a stroke rehabilitation research trial: A qualitative evaluation using Normalisation Process Theory

Background The Implicit Learning in Stroke study was a pilot cluster randomised controlled trial, investigating the use of different motor learning strategies in acute stroke rehabilitation. Participating Stroke Units (n = 8) were from the South East/West regions of the UK, with the experimental intervention (implicit learning) being delivered by clinical teams. It required therapists to change how they gave instructions and feedback to patients during rehabilitation. This paper reports the processes underpinning implementation of the implicit learning intervention. The evaluation aimed to i) understand how therapists made sense of, engaged with and interpreted the effects of the intervention; ii) compare this to the experience reported by patients; iii) extrapolate learning of broader relevance to the design and conduct of research involving complex interventions in stroke rehabilitation. Methods Qualitative evaluation, with data collected through focus groups with clinical staff (n = 20) and semi structured interviews with people with stroke (n = 19). Mixed inductive and theory driven analysis, underpinned by Normalisation Process Theory. Results How therapists made sense of and experienced the intervention impacted how it was implemented. The intervention was delivered by individual therapists, and was influenced by their individual values, beliefs and concerns. However, how teams worked together to build a shared (team) understanding, also played a key role. Teams with a more “flexible” interpretation, reported the view that the intervention could have benefits in a wide range of scenarios. Those with a more fixed, “rule based” interpretation, found it harder to implement, and perceived the benefits to be more limited. Therapists’ concerns that the intervention may impair therapeutic relationships and patient learning were not reflected in how patients experienced it. Conclusions Changing practice, whether in a research study or in the “real world”, is complex. Understanding the process of implementation is crucial to effective research delivery. Implementation frameworks facilitate understanding, and subsequently the systematic and iterative development of strategies for this to be addressed. How teams (rather than individuals) work together is central to how complex interventions are understood and implemented. It is possible that new complex interventions work best in contexts where there are ‘flexible’ cultures. Researchers should consider, and potentially measure this, before they can effectively implement and evaluate an intervention. Trial registration Clinical Trials - NCT03792126.


About the IMPS Trial
This document contains guidance on the Implicit Learning Approach (ILA).Your service has been randomised to the intervention arm of the IMPS Trial.This guidance, alongside the training package, will help you to adopt an implicit learning approach for participants enrolled in the study.
For participants who are enrolled in the study, we are asking you to use the ILA for all rehabilitation sessions that focus on sitting, sit to stand, stepping, transfers and gait.This is from the point of enrolment, until discharge from hospital.It is important that participants in the trial receive rehabilitation that is strongly biased towards the ILA.To do this, you need to adopt coaching behaviours that will promote implicit learning processes.
The guidance outlines the principles of implicit learning, and provides a series of examples for how common exercises could be adapted to bias the implicit system.You can use these exercises and/or adapt them for the individual.You can also create your own exercises; as long as they follow they remain true to the ILA principles, which are to:  Reduce the quantity of verbal coaching statements that you give (instructions and feedback) and;  Promote an external focus of attention as much as possible.
Further information about the study design and process can be found in the IMPS Protocol.

The Implicit Learning Approach
What is Implicit Learning?
Implicit learning occurs when the performer (in this case, the patient), does not gain verbal knowledge of movement performance (e.g.facts and rules about how to move) (1).It is often describe as learning without awareness.
In contrast, someone who is learning explicitly will be able to describe how they are moving.They will know and be able to verbalise facts or rules, such as: "I am not controlling my knee very well" "I know that I need to focus on picking up my foot and putting my heel down first".
During implicit learning, the performer does not accumulate these types of facts or rules.They cannot easily describe how they are moving or what they need to do differently, but they might be able to show you.It is a more automatic and subconscious form of learning.
To promote implicit learning, we are providing guidance on how you can alter the delivery of rehabilitation, by changing elements relating to:  Instructions (timing and type)  Feedback (timing and type)  Task organisation (including focus of attention) As this is a clinically grounded trial, you have the freedom to tailor the specific content of each treatment session to patient need.You will need to adapt your approach depending on the skills and ability of the patient.However, you must remain true to the principles of the ILA.The aim is to create a strong bias toward implicit learning processes.

Frequency of Coaching Statements
The term coaching statements refers to verbal instructions, feedback and motivational statements (e.g.good, keep going, and another).To encourage implicit learning, the quantity and frequency of coaching statements should be limited. Instructions should be given at the beginning of task practice; their focus should be external (see below)  Feedback should be given at the end of a series of repetitions and/or delayed; it's focus should be external (see below)  Concurrent instructions and feedback (i.e.given during task practice) should be avoided.
In addition, the content should be simple.
 Use as few words as possible to convey the message.

Focus of Attention
The term focus of attention refers to the location of an individual's attention in relation to the performance environment/task.It can be either internal or external.
 An internal focus is directed toward components of the body movement, where the learner will be consciously aware of how they are performing. An external focus is directed toward the effect of the movement on the environment, or the end goal.
To promote implicit learning, an external focus of attention should be used.To achieve this, the mention of body parts should be minimised.
 The task and the instruction should always focus on the outcome of the targeted movement to maintain a bias toward an external focus (e.g.tap the marker).
 The movement required to achieve an outcome should not be mentioned (e.g.do not say -lift your foot; or bend your hip).
 When required for clarity, the body part itself can be mentioned (e.g.tap your foot onto the marker), but efforts should be made to minimise this.
In summary, to promote implicit learning:  SAY LESS! Use fewer instructions and feedback and;  KEEP THE FOCUS EXTERNAL.You might need to adjust the task, to facilitate this.V1, 29.1.2019

Ideas for how to promote an External Focus of Attention
To promote an external focus of attention, you may need to do more than just change your instruction.You may also need to think about what the exercise/task is specifically aiming to achieve, and then alter the set-up to facilitate this.The table below includes ideas for promoting an external focus of attention:

Exercise Examples IMPS 1
Instruction: Hit the buzzer with the back of the skateboard Notes: For eliciting knee flexion and ankle DF -required for adequate foot placement prior to STS Set Up: Target line in front; buzzer behind.Non-affected foot on block for symmetry/posture.Progression: Add a weight to the skateboard for strengthening Regression: Bring the buzzer closer to enable success

IMPS 2
Instruction: Keep against the red spot/wall.Notes: For eliciting right leg activity in sitting (pushing with right leg towards the wall).Set Up: Marker on wall, and marker placed on shoulder (e.g.tape).Ensure the patient is pushing through the hemiplegic leg.Progression: Hold it there for 5 seconds.

IMPS 3
Instruction: Clean the dots off the table, and bring yourself back to the wall Notes: Loading the affected leg in sitting -aim is to bring weight over the affected leg, and then use the leg to push back to the wall

TIMEDISTANCE
Use a buzzer or squeaker to provide an externally focussed target "Touch the buzzer like this" [demonstrate hitting a buzzer with your heel] MARKER or TARGET  Use tape to highlight desired positon (e.g. of the feet)  Include a target to aim for, or a reference point to keep to "Keep your feet/shoes behind the line" "Keep within the lines as you step" "Keep against that marker [with your hip]" OBJECT  Reaching for an object  Tapping a cup  Stepping over a beanbag "Touch the red dot" "Tap the cup without crushing it" "Step over the beanbag" Trying to achieve a certain number of repetitions within a certain time  Tying to complete a task in a faster time "See how many times you can [add task] in 30 seconds" [ideally have clock or countdown app visible] "Hold it against the marker for 5 seconds" Moving over a greater distance (e.g.reach, foot placement)  Use tram lines on the floor/wall "See how many lines you can cross" "Reach as far as the blue line"  V1, 29.1.2019 Regression: Sit closer to the wall NB -RIGHT HEMIPLEGIA IN GTHIS EXAMPLE V1, 29.1.2019

Table 1 :
 Implicit Overview of Intervention V1, 29.1.2019 Draw arcs of dots on table with whiteboard pen.Line for foot position.Close to wall on affected side.